Friday, October 17, 2008

"Misuses of EBM"

In an excellent article(1) just published in JAMA on progress in evidence-based medicine, Montori and Guyatt devote a section to the misuses of EBM, worth quoting in its entirety herewith emphasis added.

An analogy can be made between EBM and nuclear fission: it can be very powerful when used appropriately and dangerous when used inappropriately. The term evidence-based precedes many recommendations, guidelines, and algorithms that are not transparently linked to the underlying evidence base and do not represent the results of a systematic and critical appraisal of that evidence. It sometimes appears as if using the term obviates the need to describe the quality of underlying evidence, the magnitude of effects, or the applicability of any of the results in the context, values, and preferences of the patients.

This is particularly problematic because the EBM era has coincided with a dramatic increase in the for-profit funding of research. Researchers funded by industry interpret their results differently and in favor of the industry product relative to not-for-profit funding. Problems associated with industry funding include use of inappropriate control interventions, surrogate outcomes, publication and reporting bias, and misleading descriptions and presentations of research findings—all forms of corrupting the evidence base. Unsophisticated users of the medical literature, assuming that medical editors, peer reviewers, and topic experts have now become familiar with the tenets of EBM, may trust these corrupted research reports and advocate for their application in practice.

Many medical schools and training programs, in a form of premature closure, are moving away from teaching the fundamentals of careful evidence appraisal to emphasize the implementation of evidence. The intent of this new focus is to produce high-quality, safe, and low-cost care (ie, Accreditation Council for Graduate Medical Education competencies of systems-based practice and improvement and practice-based learning14). However, abandoning appropriate skepticism regarding the effectiveness of these interventions may lead to large investments in quality-improvement, safety, and efficiency activities that fail to yield the expected benefits.


We are truly making progress when there is now such public recognition of threats to evidence-based medicine, and thus to the rational and compassionate practice of medicine based clinical knowledge, and on both critical review of the best available clinical evidence, and sensitivity to patients' values.

I should underline the points made in the last paragraph quoted. It is distressing that what little progress in making evidence-based medicine part of medical education we made in the 1980s and 1990s is being wiped out. But what should we expect of medical schools staffed by faculty and faculty leaders who mostly are paid by the companies that make the drugs and devices that are the subject of their teaching and research?(2-3) And what should we expect of medical schools that now depend on large infusions of money from these same companies? Truly rigorous EBM might actually show that some of these "innovative" drugs and devices are not quite as good as the marketing says. So teaching same may distress the faculty's employers and the university's benefactors.

If we expect the teaching of rational and compassionate medicine that puts the benefit of patients first, we need medical schools and medical faculty who are not paid by companies whose first priority is increasing profits by selling as many drug doses and devices they can.

References

1. Montori VM, Guyatt GH. Progress in evidence-based medicine. JAMA 2008; 300: 1814-1816. Link
here.

2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.

3. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link here.

5 comments:

Anonymous said...

An Oct. 1 WSJ Health Blog article highlights a Ben Brewer article in the paper lamenting the lack of time to see 28 patients, write for the WSJ, fill out, and fax a request for approval of Celebrex for a patient. Of interest were the comments, mostly negative, where a pharmacist questioned the use of this drug given it's profile and cost. The immediate response from another doctor was that they, doctors, needed to prescribe certain drugs, even if the data did not support their use.

Today's WSJ Health Blog highlighted this story: October 17, 2008, 8:00 am
Pfizer Agrees to Pay $894 Million in Bextra, Celebrex Settlement Posted by Scott Hensley. From the outside one has to question the use of a drug involved in litigation for adverse side effects. Certainly the evidence here would point to a very limited use for this drug, add in the cost, and this would have to be a drug of last resort.

While it is understandable doctors want the freedom to prescribe as they see fit, it is also understandable that they have a responsibility to their patients to provide the best proven therapy at the best cost point. Doctors often state they have no concept of cost associated with certain drugs. They also appear not to have much concept of the profile of those same drugs.

Steve Lucas

Paul Maurice Martin said...

Great article. It's hard to overestimate the magnitude of both the power and corruption of health care today. Of course, we should really all use "Healthcare," the sexy streamlined "it's all about business" term.

Every time a new catch phrase is trotted out one may well suspect it's another fig leaf. For example, "preventive medicine" nicely insinuates to the healthy general public that those folks who get sick and whine about the quality of care - well, it's their own darn fault. They must have drank, smoked, done drugs and had one too many Big Macs.

Anonymous said...

We have seen this weekend the broad release of a Scottish study regarding aspirin therapy as a preventer of cardiovascular events and how it was no better than placebo in a more general population. The question becomes: How long will aspirin therapy continue to prescribed to patients?

My guess is a very long time.

Steve Lucas

Anonymous said...

I like the nuclear fission metaphor. EBM is a tool, a technique. It can be used for good or ill.

Here is another. The realm of Statistics, in which the EBM nation exists, is replete with shadows, fog and camouflaged areas in which to obfuscate and cloud the Truth. Many within the land of Statistics can easily dupe outside observers into believing their version of the Truth. Only those who live and breath the lingua franca in Statistics land can really communicate with each other; and they are a rare breed indeed.

I would hypothesize that practicing physicians, if tested, would miserably fail anything but the most elementary statistical examination. A P-value here and and a sensitivity there; that's about it. Yet is it the heart of what academics and marketers use to communicate and investigate the Truth. It is easy to see how a pharmaceutical COMPANY, whose fiduciary obligations to those that give it life, frames Truth. Truth be damned if it is not aligned with its goals, i.e. profit-making extensions.

But the decisions based in profit-making impact more than a pharmaceutical company's bottom line. Real lives hang in the balance. That last 20 years of America's neo-capitalism and its greed-is-good values that have come with it do not give me much confidence that business can be trusted given the stakes.

America and the world are reeling from the latest financial crisis, fueled by the same greed. Do we have the collective courage to confront similar forces in the Healthcare arena?

Anonymous said...

Ya, I don't like when industrial music is called EBM. Electronic Body Music

http://en.wikipedia.org/wiki/Electronic_body_music

Silly scientists can't distinguish between industrial and EBM.